Dasotraline for ADHD
Dasotraline is a dopamine and norepinephrine reuptake inhibitor that is currently being tested for use in ADHD.12
In a placebo-controlled double-blind study, a single daily dose of 8 mg dasotraline (but not 4 mg dasotraline) showed significant improvement in ADHD-HI Rating Scale (ADHD-HI) symptoms and CGI-S scores at 4 weeks compared with placebo.3
Side effects were mainly:
- Sleep problems
- Dry mouth
- Loss of appetite
- Nausea
At 4 mg, a good 10% of subjects terminated the study prematurely, at 8 mg just under 28%. This appears to be quite high.
The high insomnia could result from the long half-life of 47 hours, which, on the other hand, would allow a daily single dose leading to a constant plasma level after 10 days of intake.45
On the other hand, insomnia was not a predictor of dropout from study participation.
Wigal, Hopkins, Koblan, Childress, Kent, Tsai, Hsu, Loebel, Goldman (2019): Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study. J Atten Disord. 2019 Aug 2:1087054719864644. doi: 10.1177/1087054719864644. ↥
Roll, Hahn (2016): Neue medikamentöse Behandlungsansätze. DNP – Der Neurologe und Psychiater. March 2016, Volume 17, Issue 3, pp 23–24 ↥
Koblan, Hopkins, Sarma, Jin, Goldman, Kollins, Loebel (2015): Dasotraline for the Treatment of Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Neuropsychopharmacology. 2015 Nov;40(12):2745-52. doi: 10.1038/npp.2015.124. PMID: 25948101; PMCID: PMC4864650. n = 331 ↥
Hopkins, Sunkaraneni, Skende, Hing, Passarell, Loebel, Koblan (2016): Pharmacokinetics and Exposure-Response Relationships of Dasotraline in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults. Clin Drug Investig. 2016 Feb;36(2):137-46. doi: 10.1007/s40261-015-0358-7. PMID: 26597180; PMCID: PMC4740560. ↥
Roll, Hahn (2016): Neue Studien zu ADHS im Erwachsenenalter. DNP – Der Neurologe & Psychiater > Ausgabe 6/2018 ↥